Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines

Kadam, Abhay; Maigetter, Karen; Jeffery, Roger; Mistry, Nerges; Weiss, Mitchell G.; Pollock, Allyson M

doi:10.15171/ijhpm.2016.44

Cited by 6 publications

(10 citation statements)

References 3 publications

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“…In 2020, the DGDA maintains offices in only 47 out of the 64 districts of Bangladesh, indicative of structural challenges (18,29). These challenges are similar for other LMICs, including the world's largest generics manufacturer, India (30,31).…”

Section: Policy Provisions Enforcement and Regulatory Capacity Challengesmentioning

confidence: 84%

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Orubu

Samad

Rahman

et al. 2021

Preprint

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Poor-quality medicines lead to large individual, health systems and national economic losses. Most low- and middle-income countries (LMICs) lack the robust regulatory quality assurance system necessary to contain the spread of poor-quality medicines. Innovations in regulatory systems strengthening are needed to protect public health. In this study, we assessed the integrity of the antimicrobial supply chain in Bangladesh and suggest innovations. We employed a qualitative methodology comprising a policy content analysis, and literature and database reviews. Bangladesh was chosen as a model LMIC because of its pharmaceuticals production capacity. Using a framework modified from the World Health Organization’s and the United States Pharmacopoeia’s, the Bangladesh National Drug Policy (BNDP) was evaluated for provisions on quality assurance mechanisms that match regulatory functions. Newspaper, peer-reviewed and post-marketing surveillance reports were used to assess the extent of poor-quality antimicrobials in circulation. There are provisions for quality assurance in the BNDP. Newspaper reports identified the circulation of substandard antimicrobials and reported on actions by the government to seize fraudulent/falsified and expired products. Only six peer-review studies testing antimicrobial product quality were identified; the three studies with the larger sample size (over 10 samples tested) reported results of out-of-specifications products. This assessment found evidence of regulatory actions against poor-quality antimicrobials as well as news reports and studies suggesting quality concerns, but no current rigorous assessment of the extent in Bangladesh. We suggest a multi-pronged approach to regulatory system strengthening comprising three strategies: community-based surveillance, task-shifting, and technology-enabled consumer participation.

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Section: Policy Provisions Enforcement and Regulatory Capacity Challengesmentioning

confidence: 84%

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Orubu

Samad

Rahman

et al. 2021

Preprint

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“…A further reason why we chose Maharashtra as the location for this research is it has the largest number of manufacturing plants of all Indian states, contributing to 38% of the country’s medicine exports [ 30 ]. It also has the largest number of sales units, which the Maharashtra Food and Drug Administration estimates at 80 000 [ 31 ].…”

Section: Methodsmentioning

confidence: 99%

Availability of brands of six essential medicines in 124 pharmacies in Maharashtra

Millard

Kadam

Mahajan

et al. 2018

Journal of Global Health

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BackgroundThe aim of this study is to assess the availability and rational use of six essential medicines in private retail outlets in Maharashtra state. The study focuses on the range of brands for each medicine, and the availability of these brands in the pharmacies. The medicines were chosen because they are included in the World Health Organization’s (WHO) essential medicines list (EML), the Indian national and Maharashtra state medicines list, and are all included in existing Indian public health initiatives and national disease control programmes.MethodsData was gathered on the availability of the medicines and the range and frequency of brands in 124 private retail pharmacies between January and May 2012. As there is currently no centralised database in India of available pharmaceutical brands, we collected data on the range of products of the 6 essential medicines available in the Indian market by consulting three open access Indian pharmaceutical databases, CIMS India, Medindia, and Medguide, and the commercial database, Pharmatrac; we compared this data with the results of the survey. The six essential medicines used in this study are: artemisinin (malaria), lamivudine (HIV/AIDS), rifampicin (tuberculosis control), oxytocin (reproductive health), fluoxetine (mental health) and metformin (diabetes).ResultsThe study found that for each of the selected medicines there were multiple approved products listed in Indian databases, 2186 in total. The Pharmatrac database lists only 1359 brands of the selected medicines; 978 (72%) of these had zero sales in 2011-2012. Our survey found very low availability of the brands: 17% Pharmatrac marketed brands (163/978) and 12% of all Pharmatrac brands (163/1359) were available. Metformin was the only medicine with high availability in the study pharmacies at 91%, Rifampacin was the second highest at 64.5%; the other four medicines were available in less than half the pharmacies. A small number of brands were dominating the market.Conclusionthe survey shows that market competition has generated a large number of brands of the six study medicines but this has not translated into sufficient availability of these medicines in the study pharmacies. The data calls for a review of available brands, taking into consideration levels of sale and grounds for approval, and the setting up of a centralised database of registered pharmaceutical products.

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“…In 2020, the DGDA maintained offices in only 47 of the 64 districts of Bangladesh, indicative of structural challenges [18,29]. These challenges are similar for other LMICs, including the world's largest generics manufacturer, India [30,31].…”

Section: Policy Provisions Enforcement and Regulatory Capacity Challe...mentioning

confidence: 99%

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Orubu

Samad

Rahman

et al. 2022

J Public Health Pol

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Most low-and middle-income countries lack the regulatory capacity to contain substandard and falsified (SF) medicines. Innovations for strengthening regulatory systems are needed to protect public health. We assessed the integrity of the antimicrobial supply chain in Bangladesh. We employed qualitative methods comprising policy content analysis, and literature and database reviews. Using a framework modified from the World Health Organization's and the United States Pharmacopoeia's, the Bangladesh National Drug Policy (BNDP), was evaluated for provisions on medicines quality assurance mechanisms. We used newspaper, peer-reviewed, and post-marketing surveillance reports to assess prevalence of SF antimicrobials. The BNDP contains provisions for quality assurance. Newspaper reports identified circulation of substandard antimicrobials. We identified only six peer-review studies testing antimicrobial product quality with three studies reporting out-of-specifications products. We suggest three strategies for strengthening the regulatory system: community-based surveillance, task shifting, and technology-enabled consumer participation.

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Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines

Cited by 6 publications

References 3 publications

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

Availability of brands of six essential medicines in 124 pharmacies in Maharashtra

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges

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